Quality Assurance Pharmacist
Branch Office of Boehringer Ingelheim RCV GmbH & Co KG
THE POSITION
We are looking for a GDP Responsible Person in Budapest, Hungary:
The primary responsibility of the role is to perform local release of the incoming products for distribution. Supports Quality and Compliance Manager to maintain local quality system. Ensures that processes in the warehouse comply with the local and EU regulation.
ensuring that a quality management system is implemented and maintained;focusing on the management of authorized activities and the accuracy and quality of records;ensuring that initial and continuous training programs are implemented and maintained;coordinating and promptly performing any recall operations for medicinal products;ensuring that suppliers and customers are approved;approving any subcontracted activities which may impact on GDP;ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective and preventive measures are put in place;keeping appropriate records of any delegated duties;deciding on the final disposition of returned, rejected, recalled or falsified products;approving any returns to saleable stock;transferring products to saleable stock according to local and EU regulations;supervising the warehousing, transporting and repackaging activity of the Local Service Provider (including validation, qualification and calibration);following-up the changes of local and EU legislation;ensuring that any additional requirements imposed on certain products by national law, are fulfilled, i.e.:66/2012 decree of the cabinet53/2004 ESzCsM – ministry decree128/2009 FVM – ministry decreeBe a back-up for the Quality and Compliance Manager regarding quality topics including the management of technical product complaints (Human Pharma and Animal Health)REQUIRED DEGREE / EDUCATION / EXPERIENCE
PharmacistBackground in Quality Management and at least 1 year of experience in the field of GDP as Responsible PersonVerbal and written communication skills in EnglishNative Hungarian knowledgeREQUIRED SKILLS / COMPETENCIES
Basic computer skills (Microsoft, SAP)Good problem-solving capabilitiesQuality mindsetTeam playerWHAT WE OFFER
Competitive compensation package, learning & development opportunities.
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